NCT01100476

Mynx M5 One Hour Ambulation Study

Single-center, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control (Diagnostic Arm of the Mynx 6/7F Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Cardiovascular Associates of the Delaware Valley · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Mynx Vascular Closure Device (Mynx M5) is a sponge-like material used to close the hole in the artery after patients undergo a diagnostic endovascular procedures

Detailed description

Key Inclusion: 1. Patients \>18 yrs of age 2. Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath via the common femoral artery. 3. Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by investigator.

Conditions

• Angiography

Interventions

Type	Name	Description
DEVICE	Endovascular Diagnostic Procedures	Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-04-09
• Last updated: 2013-02-15

Locations

1 site across 1 country: United States